Trial Search Results
A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Participants Undergoing Hematopoietic Cell Transplants (HCTs) (V212-001)
This is a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of inactivated VZV vaccine for the prevention of HZ and HZ-related complications in adult recipients of autologous hematopoietic cell transplants (HCTs). The primary hypothesis is that vaccination with V212 vaccine will reduce the incidence of herpes zoster (HZ) compared to placebo when administered to recipients of HCT. The statistical criterion for success requires that the lower bound of the 95% confidence interval for the estimated vaccine efficacy in the V212 recipients (excluding the high-antigen lot) compared with that in the placebo recipients is >25%.
Stanford is currently not accepting patients for this trial.
Merck Sharp & Dohme Corp.
- Biological: V212
- Biological: Matching placebo
- Has prior history of varicella, antibodies to VZV (documented prior to receipt of
blood products), or residence in a country with endemic VZV infection for ≥30 years or
if participant is <30 years old, attended primary or secondary school in a country
with endemic VZV infection.
- Scheduled to undergo an autologous hematopoietic cell transplant within 60 days of
- Is highly unlikely to conceive during the time period starting 2 weeks prior to
enrollment through 6 months from last vaccination dose
- Female participants of childbearing potential must have a negative serum or urine
- History of hypersensitivity reaction to any vaccine component
- Prior history of herpes zoster within 1 year of enrollment
- Prior receipt of any varicella or zoster vaccine
- More than 2 relapses of the underlying cancer (participants with Hodgkin's lymphoma
may have had more than 2 relapses)
- Expectation of tandem transplant procedure
- Is expected to receive >6 months (>180 days) of prophylactic antiviral therapy
- Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks
prior to enrollment through 6 months from last vaccination dose.
- Has received a live virus vaccine or is scheduled to receive a live virus vaccine in
the period from 4 weeks prior to Dose 1 through 28 days Postdose 4.
- Has received an inactivated vaccine or is scheduled to receive an inactivated vaccine
in the period between 7 days prior to and 28 days following Doses 1 through 4.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study